Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
NCT ID: NCT05677048
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
205 participants
INTERVENTIONAL
2023-04-14
2027-10-31
Brief Summary
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The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.
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Detailed Description
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The primary objectives of this study are to assess the study feasibility by estimating:
1. The enrollment of probands and (ARRs) at-risk relatives over a 6-month period
2. The response rate to baseline and follow-up surveys by probands
3. The response rate to baseline and follow-up surveys by (ARRs) at-risk relatives
Secondary Objectives:
The secondary objectives of this study are to:
1. Measure (ARR) at-risk relatives completion of (CGT) cascade genetic testing among different study arms.
2. Measure the proportion of enrolled (ARRs) at-risk relatives who make an informed decision about (CGT) cascade genetic testing.
3. Measure the (ARR) at-risk relatives readiness for (CGT) cascade genetic testing
4. Measure proband and (ARR) at-risk relatives change in genetics knowledge
5. Measure proband readiness to communicate results of genetic testing with (ARR) at-risk relatives Secondary objectives in this feasibility study will be primary objectives in a larger study. This feasibility study is not powered to assess these objectives. Including them in this feasibility study will allow for assessment of our measurement tools (surveys from primary objectives) and offer insight into how the intervention may impact cascade genetic testing when implemented on a larger scale
Exploratory Objectives:
The exploratory objectives in this study are to estimate:
1. The average website traffic of the IGNITE-TX "Hub" and module completion
2. The average utilization of family genetic navigators by participants
3. Estimate the intra-familial correlation (IFC) for (ARR) at-risk relatives completion of (CGT) cascade genetic testing
4. Assess satisfaction with IGNITE-TX website modules and genetic navigator The exploratory objectives will allow for further evaluation of the IGNITE-TX website modules and navigator and understand how families with multiple (ARR)at-risk relatives respond to the intervention.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group 1 (Standard of Care Group)
Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing.
Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing
No interventions assigned to this group
Group 2 (Free genetic testing and counseling group)
Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study
Free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing
IGNITE-TX Group
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
IGNITE-TX and free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator
Group 3 (IGNITE-TX Group)
Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm
Free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing
IGNITE-TX Group
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
IGNITE-TX and free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator
Group 4 (IGNITE-TX and free genetic testing and counseling group)
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator
Free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing
IGNITE-TX Group
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
IGNITE-TX and free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator
Interventions
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Free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing
IGNITE-TX Group
Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator
IGNITE-TX and free genetic testing and counseling group
Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator
Eligibility Criteria
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Inclusion Criteria
2. Speaks and/or reads English or Spanish
3. Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS)
4. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number
2. Has negative germline genetic testing or only variant of uncertain significance
3. Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR)
1. 18 years of age or older
2. Speaks and reads English or Spanish
3. Resides in the United States
4. Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling)
5. Has access to internet or phone and can send and receive email and/or text messages at a US telephone number
Exclusion Criteria
2. Reports no known HBOC or LS variant within the family
3. Has already been tested for the variant identified in the proband
4. Already listed as an ARR for another proband
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jose Rauh-Hain, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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FP00015533
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCI-2022-10573
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0712
Identifier Type: -
Identifier Source: org_study_id
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